MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:5MM L:310MM; LIGATION / VESSEL CLIPS

Model Number PL522R

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If additional information is received a follow up report will be submitted.

Event Description

It was reported the clip magazine broke intra-operatively.During robotic surgery for prostate malignant tumor, the clip magazine broke.It was noted the part of the clip magazine (distal end) was broken and its broken piece was missing (most likely remaining in the patient.) the surgeon stated that the clip magazine detached from the applier after a few instances/times of clipping.A review of the intra-operative video was done but it could not be verified/confirmed how or when the clip magazine broke.The surgeon searched for the broken part in the abdomen, but was unable to find any plastic parts of the device.The surgeon elected to close the incision as it was unlikely that the plastic part would be found.No patient information has been provided.Associated medwatch: 9610612-2019-00215.

Manufacturer Narrative

Aesculap inc.(importer, registration no.(b)(4)) is submitting this report on behalf of aesculap ag (manufacturer, registration no.(b)(4)).Exemption number: e2014018.Investigation: vigilance investigator carried out the pictorial documentation visually and microscopically.The investigation was carried out by the q-coordinator of the production plant.The retention force of the cartridge is only 1.7 newton instead of 2 newton.Furthermore, the jaw parts are bent and no longer even, therefore a proper transport of the clip is no longer guaranteed.Both deviations together are probably the root cause for loosening the cartridge.The analysis of the fracture pattern of the cartridges illustrated a forced fracture due to overload.No pores, inclusions or foreign bodies could be found on the point of rupture.According to the provided pictures of the customer, the distal end of cartridge "a" was not broken before shipping.The breakage of cartridge "a" was found in qla.Therefore, we assume the cartridge was damaged during transport or reprocessing.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot numbers are unknown.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient usage.Rationale: since the jaws are no longer even, a correct function can no longer guaranteed.This was most likely the cause of the damage and the intraoperatively loss of the cartridge.The deviations of the shaft were most likely caused by an overload situation, e.G.During handling or reprocessing.A capa is not necessary.Associated medwatches: 9610612-2019-00215 and 9610612-2019-00256.

• Brand Name: SHAFT COMPL.D:5MM L:310MM
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8479155
• MDR Text Key: 140799849
• Report Number: 9610612-2019-00216
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL522R
• Device Catalogue Number: PL522R
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/27/2019
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 05/27/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention