ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L

Report

Report Number: 1219930-2016-00178
Event Type: Injury
Date Received: March 1, 2016
Date of Event: February 17, 2016
Report Date: February 18, 2016
Manufacturer: COVIDIEN, FORMERLY US SURGICAL A DIVISON
Product Code: FZP
PMA / PMN Number: K071406
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

MANUFACTURER REFERENCE NUMBER: (B)(4).

Additional Manufacturer Narrative · 1

MANUFACTURER REFERENCE NUMBER: (B)(4). EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE PHOTOS, ONE DVD AND ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE HANDLE WAS FLACCID AND NOT ATTACHED TO THE INTERNAL COMPONENTS. TWO PARTIALLY FORMED CLIPS WERE RECEIVED; ONE WITH TISSUE AND THE OTHER WITHOUT TISSUE. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS WHICH REVEALED THAT THE WISHBONE LINK WHICH ATTACHES THE TRIGGER TO THE FIRING MECHANISM HAD DISENGAGED AND THE HANDLE BROKEN. TWO RATCHET PAWLS WERE OBSERVED. THE CLIP COUNTER WAS NO LONGER ACTIVE UPON RECEIPT OF THE INSTRUMENT. A REPRESENTATIVE BATTERY WAS ASSEMBLED ONTO THE SUBJECT CLIP COUNTER FOR FURTHER EVALUATION. THE RETURNED COUNTER INDEXED PROPERLY FROM 16 TO 00 WITHOUT ISSUE MULTIPLE TIMES. BASED ON THE EVALUATION OF THE RETURNED DEVICE IT WAS DETERMINED THAT THE EXTRA COMPONENT WAS MANUALLY INSERTED DURING THE MANUFACTURING PROCESS AND MAY HAVE CAUSED THE HANDLE TO LOCK DURING APPLICATION NOT ALLOWING THE JAWS TO OPEN. IN ADDITION; ALL CONTROLS AT THE NEW MANUFACTURING SITE ARE IN PLACE TO PREVENT THIS CONDITION FROM OCCURRING. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS DUE TO THE FLACCID HANDLE, EXTRA COMPONENT AND THE REPORTED CONDITION WAS CONFIRMED. REPLICATION OF THE DISENGAGED WISHBONE LINK CONDITION MAY OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. THE FILE WILL BE CLOSED AS AN ASSEMBLY ERROR, MISUSE OF THE PRODUCT AND TESTED SATISFACTORILY. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE PHOTOS, ONE DVD AND ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICE. VISUAL INSPECTION OF THE INSTRUMENT NOTED THE HANDLE WAS FLACCID AND NOT ATTACHED TO THE INTERNAL COMPONENTS. TWO PARTIALLY FORMED CLIPS WERE RECEIVED; ONE WITH TISSUE AND THE OTHER WITHOUT TISSUE. THE INSTRUMENT WAS DISMANTLED FOR VISUALIZATION OF INTERNAL COMPONENTS WHICH REVEALED THAT THE WISHBONE LINK WHICH ATTACHES THE TRIGGER TO THE FIRING MECHANISM HAD DISENGAGED AND THE HANDLE BROKEN. THE CLIP COUNTER WAS NO LONGER ACTIVE UPON RECEIPT OF THE INSTRUMENT. A REPRESENTATIVE BATTERY WAS ASSEMBLED ONTO THE SUBJECT CLIP COUNTER FOR FURTHER EVALUATION. THE RETURNED COUNTER INDEXED PROPERLY FROM 16 TO 00 WITHOUT ISSUE MULTIPLE TIMES. BASED ON THE EVALUATION OF THE RETURNED DEVICE IT WAS DETERMINED THAT THE EXTRA COMPONENT WAS MANUALLY INSERTED DURING THE MANUFACTURING PROCESS AND MAY HAVE CAUSED THE HANDLE TO LOCK DURING APPLICATION NOT ALLOWING THE JAWS TO OPEN. IN ADDITION, ALL CONTROLS AT THE NEW MANUFACTURING SITE ARE IN PLACE TO PREVENT THIS CONDITION FROM OCCURRING. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT CONFIRMED THE PRODUCT DID NOT MEET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING THE REPORTED CONDITIONS DUE TO THE FLACCID HANDLE, EXTRA COMPONENT AND THE REPORTED CONDITION WAS CONFIRMED. REPLICATION OF THE DISENGAGED WISHBONE LINK CONDITION MAY OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. A PROCESS ENHANCEMENT HAS BEEN IMPLEMENTED TO PREVENT THIS CONDITION FROM RECURRING. THIS CONDITION HAS BEEN BROUGHT TO THE ATTENTION OF THE APPROPRIATE MANUFACTURING PERSONNEL TO ENSURE THE VERIFICATION OF CORRECT PRODUCT ASSEMBLY AND INSPECTION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY AMENDED AS APPROPRIATE.

Description of Event or Problem · 1

ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, UPON THE FIRST FIRE, THE SURGEON ATTEMPTED TO FIRE THE DEVICE; HOWEVER THE JAWS DID NOT OPEN AFTER THE FIRE AND WERE UNABLE TO BE RELEASED FROM THE BLOOD VESSEL. THE REMAINING NUMBER INDICATED TEN AFTER THE FIRST FIRE AND THE HANDLE HAD A DIFFERENT FEELING FROM USUAL ¿ STIFF. SURGEON ATTEMPTED TO SQUEEZE THE HANDLE AGAIN TO OPEN THE JAWS; HOWEVER, THE JAWS DID NOT OPEN. TO REMOVE THE CLIP, HEMOCLIPS WERE PLACED ON BOTH SIDES OF THE SUBJECT CLIP AND ADDITIONAL RESECTION WAS PERFORMED. THE SUBJECT CLIP WAS REMOVED WITH BLOOD VESSEL CLAMPING. SINCE 5MM PORT WAS ADDITIONALLY INSERTED INTO THE CAVITY TO PLACE HEMOCLIPS, LESS THAN 3CM EXPANSION OF THE SURGICAL WOUND OCCURRED. THE LAST PATIENT¿S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
128514	ENDOCLIP III 5MM APPLIER W/HEMOSTAY CLIP M/L	CLIP, IMPLANTABLE	FZP	COVIDIEN, FORMERLY US SURGICAL A DIVISON	176630	N5H0278MX

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other