TECHNOMED EUROPE
Report
- Report Number
- 9710376-2022-00003
- Event Type
- Malfunction
- Date Received
- October 28, 2022
- Date of Event
- September 27, 2022
- Report Date
- October 28, 2022
- Manufacturer
- TECHNOMED EUROPE
- Product Code
- GXZ
- PMA / PMN Number
- K050325
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ON 17OCT2022: PICTURES WERE REQUESTED TO THE REPORTER AND RECEIVED. ADDITIONALLY, QUESTIONS WERE ASKED THAT STILL NEED TO BE ANSWERED. THIS TURNS OUT TO BE A SIMILAR ISSUE AS WAS REPORTED TO US BY THE SAME ORGANIZATION ON THE 31ST OF AUGUST (NCR 22-080). IN BOTH CASES, PART OF THE SHRINK SLEEVE HAS BEEN SCRAPED OFF. THIS IS EXPECTED TO OCCUR WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE IS STUCK/RETRACTED UNDER AN ANGLE, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. THE ANALYSIS OF SIMILAR EVENT NCR 22-080 HAS BEEN ASSESSED BY A TOXICOLOGIST. ON 21OCT2022 INFORMATION FROM HOSPITAL: THE COMPLETED CUSTOMER COMPLAINT QUESTIONNAIRE WAS RECEIVED FROM THE CUSTOMER. INFORMATION INCLUDES THE FOLLOWING: CONNECTING EQUIPMENT WAS FROM SPECIALTY CARE. NO OTHER EQUIPMENT/ACCESSORIES WAS USED IN CONJUNCTION WITH OR NEAR THE PRODUCT. THE PROBLEM WAS DETECTED BY THE PROVIDER REMOVING THE PROBE AND SEEING THAT A PIECE OF THE SHEATH WAS MISSING. TYPE OF PROCEDURE: L5-S1 OLLIF -DETAILS OF THE EVENT IN CHRONOLOGICAL ORDER: PROVIDER USES THE PROBE WITH METAL SHEATH TO LOCATE SPOT FOR CAGE, ONCE IT'S LOCATED, PROVIDER PUSHES METAL SHEATH AND REMOVES PROBE. HE REMOVED THE PROBE AND NOTICED THE BLACK SHEATH ON PROBE WAS MISSING. PROVIDER CONTINUED TO USE AFFECTED PROBE UNTIL DONE. PRODUCT WAS CHECKED AT THE START. PRODUCT WAS INTACT AT THE START. ON 24OCT2022 MEETING BETWEEN TECHNOMED, SURGEON AND HOSPITAL STAFF THIS SURGEON IS PERFORMING A SPECIAL APPROACH TO OLIF (OBLIQUE LATERAL INTERBODY FUSION), WHICH IS A MINIMALLY INVASIVE SOLUTION FOR CORRECTION OF DEGENERATIVE AND DEFORMITY SPINAL CONDITIONS. HE HAS SUGGESTED HE IS THE ONLY ONE IN THE WORLD PERFORMING THIS SPECIAL APPROACH. THIS IS A MINIMALLY INVASIVE TECHNIQUE WITH SMALL WOUNDS AND LESS SCAR TISSUE, RESULTING IN A LOW AMOUNT OF SPACE TO MANEUVER. IN CASE THE WAY TO GET TO THE WISHED LOCATION IS NOT EXACTLY LINEAR, THE SURGEON NEEDS TO BEND THE PROBE A BIT DURING THE PROCEDURE (IT'S FLEXIBLE). WHEN LATER ON RETRACTING IT FROM THE STIFF DILATOR IN A NON-LINEAR WAY, PART OF THE SHRINK TUBE IS SCRAPED OFF. IN THIS SURGEON'S PROCEDURE, THERE CAN BE MORE FORCE NEEDED THAN IN OTHER PROCEDURES BECAUSE THIS PROCEDURE AIMS AT LEAVING SMALL SCARS, THEREFORE, THERE IS NOT MUCH ROOM TO MANEUVER AND HIGHER RISK OF BENDING THE PROBE. ON 22NOV2022: A TOXICOLOGIST CONCLUDED THAT THE HEALTH RISK ASSOCIATED WITH THIS EVENT IS MINOR. 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.
17OCT2022: PICTURES WERE REQUESTED TO THE REPORTER AND RECEIVED. ADDITIONALLY, QUESTIONS WERE ASKED THAT STILL NEED TO BE ANSWERED. THIS TURNS OUT TO BE A SIMILAR ISSUE AS WAS REPORTED TO US BY THE SAME ORGANIZATION ON THE (B)(6) ((B)(4)). IN BOTH CASES, PART OF THE SHRINK SLEEVE HAS BEEN SCRAPED OFF. THIS IS EXPECTED TO OCCUR WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE IS STUCK/RETRACTED UNDER AN ANGLE, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. THE ANALYSIS OF SIMILAR EVENT (B)(4) HAS BEEN ASSESSED BY A TOXICOLOGIST. 21OCT2022 INFORMATION FROM HOSPITAL: THE COMPLETED CUSTOMER COMPLAINT QUESTIONNAIRE WAS RECEIVED FROM THE CUSTOMER. INFORMATION INCLUDES THE FOLLOWING: CONNECTING EQUIPMENT WAS FROM SPECIALTY CARE. NO OTHER EQUIPMENT/ACCESSORIES WAS USED IN CONJUNCTION WITH OR NEAR THE PRODUCT. THE PROBLEM WAS DETECTED BY THE PROVIDER REMOVING THE PROBE AND SEEING THAT A PIECE OF THE SHEATH WAS MISSING. TYPE OF PROCEDURE: L5-S1 OLLIF. DETAILS OF THE EVENT IN CHRONOLOGICAL ORDER: PROVIDER USES THE PROBE WITH METAL SHEATH TO LOCATE SPOT FOR CAGE, ONCE IT'S LOCATED, PROVIDER PUSHES METAL SHEATH AND REMOVES PROBE. HE REMOVED THE PROBE AND NOTICED THE BLACK SHEATH ON PROBE WAS MISSING. PROVIDER CONTINUED TO USE AFFECTED PROBE UNTIL DONE. PRODUCT WAS CHECKED AT THE START. PRODUCT WAS INTACT AT THE START. 24OCT2022 MEETING BETWEEN TECHNOMED, SURGEON AND HOSPITAL STAFF: THIS SURGEON IS PERFORMING A SPECIAL APPROACH TO OLIF (OBLIQUE LATERAL INTERBODY FUSION), WHICH IS A MINIMALLY INVASIVE SOLUTION FOR CORRECTION OF DEGENERATIVE AND DEFORMITY SPINAL CONDITIONS. HE IS THE ONLY ONE IN THE WORLD PERFORMING THIS SPECIAL APPROACH. THIS IS A MINIMALLY INVASIVE TECHNIQUE WITH SMALL WOUNDS AND LESS SCAR TISSUE, RESULTING IN A LOW AMOUNT OF SPACE TO MANEUVER. IN CASE THE WAY TO GET TO THE WISHED LOCATION IS NOT EXACTLY LINEAR, THE SURGEON NEEDS TO BEND THE PROBE A BIT DURING THE PROCEDURE (IT'S FLEXIBLE). WHEN LATER ON RETRACTING IT FROM THE STIFF DILATOR IN A NON-LINEAR WAY, PART OF THE SHRINK TUBE IS SCRAPED OFF. IN THIS SURGEON'S PROCEDURE, THERE CAN BE MORE FORCE NEEDED THAN IN OTHER PROCEDURES BECAUSE THIS PROCEDURE AIMS AT LEAVING SMALL SCARS, THEREFORE, THERE IS NOT MUCH ROOM TO MANEUVER AND HIGHER RISK OF BENDING THE PROBE.
COMPLAINT DESCRIPTION FROM FDA REPORT FROM USER (MW5112363) WHEN REMOVING PROBE FROM METAL SHEATH, DR NOTICED THE PROBE SHEATH WAS MISSING. ALL PIECES RETRIEVED. FDA SAFETY REPORT ID # (B)(4). THIS MEANS THAT PART OF THE ISOLATION/SHRINK TUBE CAME OFF. ON 17OCT2022, PICTURES WERE REQUESTED TO THE REPORTER AND RECEIVED. ADDITIONALLY, QUESTIONS WERE ASKED THAT STILL NEED TO BE ANSWERED. THIS TURNS OUT TO BE A SIMILAR ISSUE AS WAS REPORTED TO US BY THE SAME ORGANIZATION ON THE 31ST OF AUGUST (NCR 22-080). IN BOTH CASES, PART OF THE SHRINK SLEEVE HAS BEEN SCRAPED OFF. THIS IS EXPECTED TO OCCUR WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE IS STUCK/RETRACTED UNDER AN ANGLE, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. THE ANALYSIS OF SIMILAR EVENT NCR 22-080 HAS BEEN ASSESSED BY A TOXICOLOGIST. ON 21OCT2022 INFORMATION FROM HOSPITAL: THE COMPLETED CUSTOMER COMPLAINT QUESTIONNAIRE WAS RECEIVED FROM THE CUSTOMER. INFORMATION INCLUDES THE FOLLOWING: CONNECTING EQUIPMENT WAS FROM SPECIALTY CARE. NO OTHER EQUIPMENT/ACCESSORIES WAS USED IN CONJUNCTION WITH OR NEAR THE PRODUCT. THE PROBLEM WAS DETECTED BY THE PROVIDER REMOVING THE PROBE AND SEEING THAT A PIECE OF THE SHEATH WAS MISSING TYPE OF PROCEDURE: L5-S1 OLLIF DETAILS OF THE EVENT IN CHRONOLOGICAL ORDER: PROVIDER USES THE PROBE WITH METAL SHEATH TO LOCATE SPOT FOR CAGE, ONCE IT'S LOCATED, PROVIDER PUSHES METAL SHEATH AND REMOVES PROBE. HE REMOVED THE PROBE AND NOTICED THE BLACK SHEATH ON PROBE WAS MISSING. PROVIDER CONTINUED TO USE AFFECTED PROBE UNTIL DONE. -PRODUCT WAS CHECKED AT THE START. PRODUCT WAS INTACT AT THE START. ON 24OCT2022 MEETING BETWEEN TECHNOMED, SURGEON AND HOSPITAL STAFF THIS SURGEON IS PERFORMING A SPECIAL APPROACH TO OLIF (OBLIQUE LATERAL INTERBODY FUSION), WHICH IS A MINIMALLY INVASIVE SOLUTION FOR CORRECTION OF DEGENERATIVE AND DEFORMITY SPINAL CONDITIONS. HE HAS SUGGESTED HE IS THE ONLY ONE IN THE WORLD PERFORMING THIS SPECIAL APPROACH. THIS IS A MINIMALLY INVASIVE TECHNIQUE WITH SMALL WOUNDS AND LESS SCAR TISSUE, RESULTING IN A LOW AMOUNT OF SPACE TO MANEUVER. IN CASE THE WAY TO GET TO THE WISHED LOCATION IS NOT EXACTLY LINEAR, THE SURGEON NEEDS TO BEND THE PROBE A BIT DURING THE PROCEDURE (IT'S FLEXIBLE). WHEN LATER ON RETRACTING IT FROM THE STIFF DILATOR IN A NON-LINEAR WAY, PART OF THE SHRINK TUBE IS SCRAPED OFF. IN THIS SURGEON'S PROCEDURE, THERE CAN BE MORE FORCE NEEDED THAN IN OTHER PROCEDURES BECAUSE THIS PROCEDURE AIMS AT LEAVING SMALL SCARS, THEREFORE, THERE IS NOT MUCH ROOM TO MANEUVER AND HIGHER RISK OF BENDING THE PROBE. 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 FDA REPORT FROM USER (MW5112363). WHEN REMOVING PROBE FROM METAL SHEATH, DR NOTICED THE PROBE SHEATH WAS MISSING. ALL PIECES RETRIEVED. FDA SAFETY REPORT ID # (B)(4). THIS MEANS THAT PART OF THE ISOLATION/SHRINK TUBE CAME OFF. 17OCT2022 PICTURES WERE REQUESTED TO THE REPORTER AND RECEIVED. ADDITIONALLY, QUESTIONS WERE ASKED THAT STILL NEED TO BE ANSWERED. THIS TURNS OUT TO BE A SIMILAR ISSUE AS WAS REPORTED TO US BY THE SAME ORGANIZATION ON THE (B)(6) ((B)(4)). IN BOTH CASES, PART OF THE SHRINK SLEEVE HAS BEEN SCRAPED OFF. THIS IS EXPECTED TO OCCUR WHEN RETRACTING THE PROBE FROM THE DILATOR WHILE THE PROBE IS STUCK/RETRACTED UNDER AN ANGLE, CAUSING PRESSURE ON THE PROBE WHILE RETRACTING. THE ANALYSIS OF SIMILAR EVENT (B)(4) HAS BEEN ASSESSED BY A TOXICOLOGIST. 21OCT2022 INFORMATION FROM HOSPITAL: THE COMPLETED CUSTOMER COMPLAINT QUESTIONNAIRE WAS RECEIVED FROM THE CUSTOMER. INFORMATION INCLUDES THE FOLLOWING: CONNECTING EQUIPMENT WAS FROM SPECIALTY CARE. NO OTHER EQUIPMENT/ACCESSORIES WAS USED IN CONJUNCTION WITH OR NEAR THE PRODUCT. THE PROBLEM WAS DETECTED BY THE PROVIDER REMOVING THE PROBE AND SEEING THAT A PIECE OF THE SHEATH WAS MISSING. TYPE OF PROCEDURE: L5-S1 OLLIF. DETAILS OF THE EVENT IN CHRONOLOGICAL ORDER: PROVIDER USES THE PROBE WITH METAL SHEATH TO LOCATE SPOT FOR CAGE, ONCE IT'S LOCATED, PROVIDER PUSHES METAL SHEATH AND REMOVES PROBE. HE REMOVED THE PROBE AND NOTICED THE BLACK SHEATH ON PROBE WAS MISSING. PROVIDER CONTINUED TO USE AFFECTED PROBE UNTIL DONE. PRODUCT WAS CHECKED AT THE START. PRODUCT WAS INTACT AT THE START. 24OCT2022 MEETING BETWEEN TECHNOMED, SURGEON AND HOSPITAL STAFF: THIS SURGEON IS PERFORMING A SPECIAL APPROACH TO OLIF (OBLIQUE LATERAL INTERBODY FUSION), WHICH IS A MINIMALLY INVASIVE SOLUTION FOR CORRECTION OF DEGENERATIVE AND DEFORMITY SPINAL CONDITIONS. HE IS THE ONLY ONE IN THE WORLD PERFORMING THIS SPECIAL APPROACH. THIS IS A MINIMALLY INVASIVE TECHNIQUE WITH SMALL WOUNDS AND LESS SCAR TISSUE, RESULTING IN A LOW AMOUNT OF SPACE TO MANEUVER. IN CASE THE WAY TO GET TO THE WISHED LOCATION IS NOT EXACTLY LINEAR, THE SURGEON NEEDS TO BEND THE PROBE A BIT DURING THE PROCEDURE (IT'S FLEXIBLE). WHEN LATER ON RETRACTING IT FROM THE STIFF DILATOR IN A NON-LINEAR WAY, PART OF THE SHRINK TUBE IS SCRAPED OFF. IN THIS SURGEON'S PROCEDURE, THERE CAN BE MORE FORCE NEEDED THAN IN OTHER PROCEDURES BECAUSE THIS PROCEDURE AIMS AT LEAVING SMALL SCARS, THEREFORE, THERE IS NOT MUCH ROOM TO MANEUVER AND HIGHER RISK OF BENDING THE PROBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2796883 | TECHNOMED EUROPE | DISPOSABLE MONOPOLAR PROBE | GXZ | TECHNOMED EUROPE | MP214-3.0/1 | 053433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |