TECHNOMED EUROPE
Report
- Report Number
- 9710376-2022-00002
- Event Type
- Malfunction
- Date Received
- September 12, 2022
- Date of Event
- August 16, 2022
- Report Date
- October 14, 2022
- Manufacturer
- TECHNOMED EUROPE
- Product Code
- GXZ
- PMA / PMN Number
- K050325
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
COMPLAINT DESCRIPTION FROM INITIAL EMAIL (29TH OF AUGUST 2022): THE TIP OF IT (DISPOSABLE MONOPOLAR PROBE) BROKE OFF DURING A SURGERY ON (B)(6) 2022. IT WAS RETAINED IN THE PATIENT. UNFORTUNATELY, THE PACKAGING OF THE INSTRUMENT WAS NOT SAVED AND THEREFORE I DO NOT HAVE THE EQUIPMENT NUMBERS AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER QUESTIONNAIRE (7TH OF SEPTEMBER 2022): DURING A L3-L5 OLLIF PROCEDURE, PROVIDER WAS REMOVING PROBE AFTER LOCATING SPOT FOR IMPLANT AND NOTED THE TIP WAS MISSING. THE BROKEN PIECE WAS LEFT IN THE PATIENT AT THE DIRECTION OF THE SURGEON DUE TO POTENTIALLY CAUSING MORE HARM IN RETRIEVING THEN LEAVING IN PLACE. PROVIDER WAS LOCATING AREA LATERALLY TO PLACE A CAGE ON THE PATIENT DURING THE SURGICAL PROCEDURE. ONCE THE SPOT WAS DETERMINED, THE PROVIDER PLACES THE METAL SHEATH IN SPOT WHERE THE PROBE GOES AND WHEN REMOVING PROBE, THE TIP WAS MISSING. DR ALERTED THE OR TEAM AND STATED THE TIP IS MISSING, WILL NEED TO OPEN ANOTHER ONE. DR STATED IT WAS STAYING THERE AS IT WOULD NOT BE APPROPRIATE TO REMOVED, COULD CAUSE HARM TO THE PATIENT TRYING TO RETRIEVE. THE TEAM REMOVED ITEM FROM STERILE FIELD. SUPPLY'S PACKAGING WAS DISCARDED AND NOT RETRIEVED AFTER THE CASE SO NO IDENTIFIERS WERE GIVEN. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER (8TH OF SEPTEMBER 2022): PICTURES SHOW THAT THE METAL BAR OF THE PROBE HAS NOT BEEN BROKEN AND HAS NOT RETAINED IN THE PATIENT. THIS IS CONFIRMED BY THE SURGEON THAT NO PIECES WERE NOTED ON X-RAY, SO NO METAL PIECES HAS BEEN RETAINED IN THE PATIENT. CAUTERY WAS OPEN FOR THE PROCEDURE, BUT IT IS NOT USED. COMMENT TECHNOMED: WE NEED MORE INFORMATION TO CONFIRM HOW THE ISOLATION WAS DAMAGED AND IF PIECES OF THE DAMAGED ISOLATION WAS RETAINED IN THE PATIENT. THIS IS ALSO NEEDED TO DETERMINE THE ROOT CAUSE.
IN ADDITION TO WHAT WAS DESCRIBED IN THE DESCRIPTION SECTION: ALTHOUGH IT WAS REPORTED BY THE INITIAL REPORTER THAT THE TIP BROKE OFF, IT COULD BE CONFIRMED THAT NO METAL PART OF THE PROBE TIP HAD BROKEN OFF. FURTHER INFORMATION IS REQUESTED. AFTER INVESTIGATION OF THE RETURNED PROBE, IT APPEARED THAT THE TIP WAS NOT BROKEN OFF BUT WAS STILL ON THE PROBE. THIS IS IN LINE WITH THE FACT THAT NO PIECES WERE SEEN ON X-RAY. THE SHRINK SLEEVE WAS PUSHED TOWARDS THE TIP, MAKING IT LOOK LIKE THE TIP BROKE OFF. BASED ON THE DAMAGE TO THE SHRINK SLEEVE, WE EXPECT THIS OCCURRED WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE WAS STUCK, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. SOME FLAKES MAY HAVE BEEN LEFT BEHIND IN THE PATIENT. THE FLAKES THAT MAY BEEN LEFT BEHIND ARE BIOCOMPATIBLE AND ACCORDING TO THE DOCTOR, TRYING TO RETRIEVE THEM WOULD CAUSE MORE RISK TO THE PATIENT THAN LEAVING THEM BEHIND. THE ADEQUACY OF THE ANALYSIS WAS CONFIRMED BY A TOXICOLOGIST. THE TOXICOLOGIST MADE SOME RECOMMENDATIONS: FURTHER CONTACTING THE CLIENT : THE CLIENT WAS CONTACTED BY E-MAIL ON THE 11TH OF OCTOBER 2022. UPDATE TO THE RISK DOCUMENT: THIS TOPIC WAS ALREADY IN THE RISK ASSESSMENT, BUT NOW IS CLARIFIED. SIMULATION STUDY: STILL TO BE PERFORMED. (UPDATE 29NOV2022: THIS HAS BEEN COMPLETED IN AN INVESTIGATION REPORT). CHECK OF DILATOR FOR DEBRIS : NO PIECES OF DEBRIS COULD BE SEEN INSIDE OF THE DILATOR OR IN THE PACKAGE IT WAS RETURNED IN. INSPECTION WAS LIMITED THROUGH THE PACKAGING BECAUSE THE PRODUCT IS CONTAMINATED WITH HUMAN MATERIAL. (THIS HAS BEEN DOCUMENTED IN AN INVESTIGATION REPORT). ON 22NOV2022: A TOXICOLOGIST CONCLUDED THAT THE HEALTH RISK ASSOCIATED WITH THIS EVENT IS MINOR, SINCE OCCURRING ONLY IN ONE CLINICAL CENTER AND THE FRAGMENT SHOULD BE CONSIDERED TO BE PART OF A PROCEDURE WHERE MORE DEBRIS IS BEING GENERATED DURING PROCEDURE AND REMOVED DURING PROCEDURE. BASED ON TOXICOLOGICAL EXPERT STATEMENT, THE HEALTH RISK IS MINOR. LOOKING AT THE REPORTING CRITERIA, BASED ON THE TOXICOLOGICAL EXPERT STATEMENT, THIS CANNOT RESULT IN DEATH, OR SERIOUS DETERIORATION IN STATE OF HEALTH, AND IS UNLIKELY TO RESULT IN SERIOUS INJURY. BECAUSE OF THAT REASON, THE EVENT IS CONSIDERED NON-REPORTABLE.
IN ADDITION TO WHAT WAS DESCRIBED IN THE DESCRIPTION SECTION: ALTHOUGH IT WAS REPORTED BY THE INITIAL REPORTER THAT THE TIP BROKE OFF, IT COULD BE CONFIRMED THAT NO METAL PART OF THE PROBE TIP HAD BROKEN OFF. FURTHER INFORMATION IS REQUESTED. AFTER INVESTIGATION OF THE RETURNED PROBE, IT APPEARED THAT THE TIP WAS NOT BROKEN OFF BUT WAS STILL ON THE PROBE. THIS IS IN LINE WITH THE FACT THAT NO PIECES WERE SEEN ON X-RAY. THE SHRINK SLEEVE WAS PUSHED TOWARDS THE TIP, MAKING IT LOOK LIKE THE TIP BROKE OFF. BASED ON THE DAMAGE TO THE SHRINK SLEEVE, WE EXPECT THIS OCCURRED WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE WAS STUCK, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. SOME FLAKES MAY HAVE BEEN LEFT BEHIND IN THE PATIENT. THE FLAKES THAT MAY BEEN LEFT BEHIND ARE BIOCOMPATIBLE AND ACCORDING TO THE DOCTOR, TRYING TO RETRIEVE THEM WOULD CAUSE MORE RISK TO THE PATIENT THAN LEAVING THEM BEHIND. THE ADEQUACY OF THE ANALYSIS WAS CONFIRMED BY A TOXICOLOGIST. THE TOXICOLOGIST MADE SOME RECOMMENDATIONS: - FURTHER CONTACTING THE CLIENT: THE CLIENT WAS CONTACTED BY E-MAIL ON THE 11TH OF OCTOBER 2022. - UPDATE TO THE RISK DOCUMENT: THIS TOPIC WAS ALREADY IN THE RISK ASSESSMENT, BUT NOW IS CLARIFIED. - SIMULATION STUDY: STILL TO BE PERFORMED. - CHECK OF DILATOR FOR DEBRIS: NO PIECES OF DEBRIS COULD BE SEEN INSIDE OF THE DILATOR OR IN THE PACKAGE IT WAS RETURNED IN. INSPECTION WAS LIMITED THROUGH THE PACKAGING BECAUSE THE PRODUCT IS CONTAMINATED WITH HUMAN MATERIAL..
COMPLAINT DESCRIPTION FROM INITIAL EMAIL (29TH OF AUGUST 2022): THE TIP OF IT (DISPOSABLE MONOPOLAR PROBE) BROKE OFF DURING A SURGERY ON (B)(6) 2022. IT WAS RETAINED IN THE PATIENT. UNFORTUNATELY, THE PACKAGING OF THE INSTRUMENT WAS NOT SAVED AND THEREFORE I DO NOT HAVE THE EQUIPMENT NUMBERS AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER QUESTIONNAIRE (7TH OF SEPTEMBER 2022): DURING A L3-L5 OLLIF PROCEDURE, PROVIDER WAS REMOVING PROBE AFTER LOCATING SPOT FOR IMPLANT AND NOTED THE TIP WAS MISSING. THE BROKEN PIECE WAS LEFT IN THE PATIENT AT THE DIRECTION OF THE SURGEON DUE TO POTENTIALLY CAUSING MORE HARM IN RETRIEVING THEN LEAVING IN PLACE. PROVIDER WAS LOCATING AREA LATERALLY TO PLACE A CAGE ON THE PATIENT DURING THE SURGICAL PROCEDURE. ONCE THE SPOT WAS DETERMINED, THE PROVIDER PLACES THE METAL SHEATH IN SPOT WHERE THE PROBE GOES AND WHEN REMOVING PROBE, THE TIP WAS MISSING. DR ALERTED THE OR TEAM AND STATED THE TIP IS MISSING, WILL NEED TO OPEN ANOTHER ONE. DR STATED IT WAS STAYING THERE AS IT WOULD NOT BE APPROPRIATE TO REMOVED, COULD CAUSE HARM TO THE PATIENT TRYING TO RETRIEVE. THE TEAM REMOVED ITEM FROM STERILE FIELD. SUPPLY'S PACKAGING WAS DISCARDED AND NOT RETRIEVED AFTER THE CASE SO NO IDENTIFIERS WERE GIVEN. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER (8TH OF SEPTEMBER 2022): PICTURES SHOW THAT THE METAL BAR OF THE PROBE HAS NOT BEEN BROKEN AND HAS NOT RETAINED IN THE PATIENT. THIS IS CONFIRMED BY THE SURGEON THAT NO PIECES WERE NOTED ON X-RAY, SO NO METAL PIECES HAS BEEN RETAINED IN THE PATIENT. CAUTERY WAS OPEN FOR THE PROCEDURE, BUT IT IS NOT USED. COMMENT TECHNOMED: WE NEED MORE INFORMATION TO CONFIRM HOW THE ISOLATION WAS DAMAGED AND IF PIECES OF THE DAMAGED ISOLATION WAS RETAINED IN THE PATIENT. THIS IS ALSO NEEDED TO DETERMINE THE ROOT CAUSE.
COMPLAINT DESCRIPTION FROM INITIAL EMAIL (ON 29TH OF AUGUST 2022): THE TIP OF IT (DISPOSABLE MONOPOLAR PROBE) BROKE OFF DURING A SURGERY ON 8.16.22. IT WAS RETAINED IN THE PATIENT. UNFORTUNATELY, THE PACKAGING OF THE INSTRUMENT WAS NOT SAVED AND THEREFORE I DO NOT HAVE THE EQUIPMENT NUMBERS AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER QUESTIONNAIRE (ON 7TH OF SEPTEMBER 2022): DURING A L3-L5 OLLIF PROCEDURE, PROVIDER WAS REMOVING PROBE AFTER LOCATING SPOT FOR IMPLANT AND NOTED THE TIP WAS MISSING. THE BROKEN PIECE WAS LEFT IN THE PATIENT AT THE DIRECTION OF THE SURGEON DUE TO POTENTIALLY CAUSING MORE HARM IN RETRIEVING THEN LEAVING IN PLACE. PROVIDER WAS LOCATING AREA LATERALLY TO PLACE A CAGE ON THE PATIENT DURING THE SURGICAL PROCEDURE. ONCE THE SPOT WAS DETERMINED, THE PROVIDER PLACES THE METAL SHEATH IN SPOT WHERE THE PROBE GOES AND WHEN REMOVING PROBE, THE TIP WAS MISSING. DR ALERTED THE OR TEAM AND STATED THE TIP IS MISSING, WILL NEED TO OPEN ANOTHER ONE. DR STATED IT WAS STAYING THERE AS IT WOULD NOT BE APPROPRIATE TO REMOVED, COULD CAUSE HARM TO THE PATIENT TRYING TO RETRIEVE. THE TEAM REMOVED ITEM FROM STERILE FIELD. SUPPLY'S PACKAGING WAS DISCARDED AND NOT RETRIEVED AFTER THE CASE SO NO IDENTIFIERS WERE GIVEN. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER (ON 8TH OF SEPTEMBER 2022): PICTURES SHOW THAT THE METAL BAR OF THE PROBE HAS NOT BEEN BROKEN AND HAS NOT RETAINED IN THE PATIENT. THIS IS CONFIRMED BY THE SURGEON THAT NO PIECES WERE NOTED ON X-RAY, SO NO METAL PIECES HAS BEEN RETAINED IN THE PATIENT. CAUTERY WAS OPEN FOR THE PROCEDURE, BUT IT IS NOT USED. COMMENT TECHNOMED: WE NEED MORE INFORMATION TO CONFIRM HOW THE ISOLATION WAS DAMAGED AND IF PIECES OF THE DAMAGED ISOLATION WAS RETAINED IN THE PATIENT. THIS IS ALSO NEEDED TO DETERMINE THE ROOT CAUSE. ADDITIONAL INFORMATION AFTER HAVING RECEIVED THE PRODUCT BACK (ON 29TH OF SEPTEMBER 2022): AFTER INVESTIGATION OF THE RETURNED PROBE, IT APPEARED THAT THE TIP WAS NOT BROKEN OFF BUT WAS STILL ON THE PROBE. THIS IS IN LINE WITH THE FACT THAT NO PIECES WERE SEEN ON X-RAY. THE SHRINK SLEEVE WAS PUSHED TOWARDS THE TIP, MAKING IT LOOK LIKE THE TIP BROKE OFF. BASED ON THE DAMAGE TO THE SHRINK SLEEVE, WE EXPECT THIS OCCURRED WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE WAS STUCK, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. SOME FLAKES MAY HAVE BEEN LEFT BEHIND IN THE PATIENT OR STAYED IN THE DILATOR TUBE. THE FLAKES THAT MAY BEEN LEFT BEHIND ARE BIOCOMPATIBLE AND ACCORDING TO THE DOCTOR, TRYING TO RETRIEVE THEM WOULD CAUSE MORE RISK TO THE PATIENT THAN LEAVING THEM BEHIND. UPDATE ON 10TH OF OCTOBER 2022: THE ADEQUACY OF THE ANALYSIS WAS CONFIRMED BY A TOXICOLOGIST. NO PIECES OF ISOLATION WERE SEEN INSIDE THE DILATOR. ON 22NOV2022: A TOXICOLOGIST CONCLUDED THAT THE HEALTH RISK ASSOCIATED WITH THIS EVENT IS MINOR, SINCE OCCURRING ONLY IN ONE CLINICAL CENTER AND THE FRAGMENT SHOULD BE CONSIDERED TO BE PART OF A PROCEDURE WHERE MORE DEBRIS IS BEING GENERATED DURING PROCEDURE AND REMOVED DURING PROCEDURE.
COMPLAINT DESCRIPTION FROM INITIAL EMAIL (29TH OF AUGUST 2022): THE TIP OF IT (DISPOSABLE MONOPOLAR PROBE) BROKE OFF DURING A SURGERY ON (B)(6) 2022. IT WAS RETAINED IN THE PATIENT. UNFORTUNATELY, THE PACKAGING OF THE INSTRUMENT WAS NOT SAVED AND THEREFORE I DO NOT HAVE THE EQUIPMENT NUMBERS AVAILABLE. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER QUESTIONNAIRE (7TH OF SEPTEMBER 2022): DURING A L3-L5 OLLIF PROCEDURE, PROVIDER WAS REMOVING PROBE AFTER LOCATING SPOT FOR IMPLANT AND NOTED THE TIP WAS MISSING. THE BROKEN PIECE WAS LEFT IN THE PATIENT AT THE DIRECTION OF THE SURGEON DUE TO POTENTIALLY CAUSING MORE HARM IN RETRIEVING THEN LEAVING IN PLACE. PROVIDER WAS LOCATING AREA LATERALLY TO PLACE A CAGE ON THE PATIENT DURING THE SURGICAL PROCEDURE. ONCE THE SPOT WAS DETERMINED, THE PROVIDER PLACES THE METAL SHEATH IN SPOT WHERE THE PROBE GOES AND WHEN REMOVING PROBE, THE TIP WAS MISSING. DR ALERTED THE OR TEAM AND STATED THE TIP IS MISSING, WILL NEED TO OPEN ANOTHER ONE. DR STATED IT WAS STAYING THERE AS IT WOULD NOT BE APPROPRIATE TO REMOVED, COULD CAUSE HARM TO THE PATIENT TRYING TO RETRIEVE. THE TEAM REMOVED ITEM FROM STERILE FIELD. SUPPLY'S PACKAGING WAS DISCARDED AND NOT RETRIEVED AFTER THE CASE SO NO IDENTIFIERS WERE GIVEN. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER (8TH OF SEPTEMBER 2022): PICTURES SHOW THAT THE METAL BAR OF THE PROBE HAS NOT BEEN BROKEN AND HAS NOT RETAINED IN THE PATIENT. THIS IS CONFIRMED BY THE SURGEON THAT NO PIECES WERE NOTED ON X-RAY, SO NO METAL PIECES HAS BEEN RETAINED IN THE PATIENT. CAUTERY WAS OPEN FOR THE PROCEDURE, BUT IT IS NOT USED. COMMENT TECHNOMED: WE NEED MORE INFORMATION TO CONFIRM HOW THE ISOLATION WAS DAMAGED AND IF PIECES OF THE DAMAGED ISOLATION WAS RETAINED IN THE PATIENT. THIS IS ALSO NEEDED TO DETERMINE THE ROOT CAUSE. ADDITIONAL INFORMATION AFTER HAVING RECEIVED THE PRODUCT BACK (29TH OF SEPTEMBER 2022): AFTER INVESTIGATION OF THE RETURNED PROBE, IT APPEARED THAT THE TIP WAS NOT BROKEN OFF BUT WAS STILL ON THE PROBE. THIS IS IN LINE WITH THE FACT THAT NO PIECES WERE SEEN ON X-RAY. THE SHRINK SLEEVE WAS PUSHED TOWARDS THE TIP, MAKING IT LOOK LIKE THE TIP BROKE OFF. BASED ON THE DAMAGE TO THE SHRINK SLEEVE, WE EXPECT THIS OCCURRED WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE WAS STUCK, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. SOME FLAKES MAY HAVE BEEN LEFT BEHIND IN THE PATIENT OR STAYED IN THE DILATOR TUBE. THE FLAKES THAT MAY BEEN LEFT BEHIND ARE BIOCOMPATIBLE AND ACCORDING TO THE DOCTOR, TRYING TO RETRIEVE THEM WOULD CAUSE MORE RISK TO THE PATIENT THAN LEAVING THEM BEHIND. UPDATE 10TH OF OCTOBER 2022: THE ADEQUACY OF THE ANALYSIS WAS CONFIRMED BY A TOXICOLOGIST. NO PIECES OF ISOLATION WERE SEEN INSIDE THE DILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1820179 | TECHNOMED EUROPE | DISPOSABLE MONOPOLAR PROBE | GXZ | TECHNOMED EUROPE | UNKNOWN, PROBABLY MP214-3.0/1 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |