MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LAPAROSCOPIC SURGERY

Model Number PL569T

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the ligating clips.During a surgical prostatectomy assisted by davinci robot, the end of the plastic housing on a clip magazine broke apart and fell into the abdomen.There was an unspecified delay and intra-operative x-ray while attempting to search for the piece.No patient injury was reported; the broken piece was not detected.Additional information was not provided.The adverse event is filed under aag reference (b)(4).Associated medwatch: clip applier pl606r.

Manufacturer Narrative

Associated medwatch-reports: (b)(4) (400441684 pl520r) and (b)(4) (400449125 pl536r).Investigation results: following components were investigated: pl520r no visible abnormalities; functional test successful, pl536r no visible abnormalities; functional test successful, pl569t #1 used condition; 5 of 8 clips withdrawn, and pl569t #2 used condition; 4 of 8 clips withdrawn; broken nose; missing fragment.Investigation was carried out visually and micrsocopically.One of two clip cartridges has a broken off nose.The broken off fragment is missing.All other components of aesculap has no abnormalities.A review of the device quality and manufacturing history records was not possible because the lot number is unknown.The root cause is most likely usage related.The fracture surface of pl569tshows no signs of material fatigue, holes, pores, or any other abnormalities, therefore we can exclude production failures.The fracture was caused most likely from external forces that have overloaded the material.This could happen, when tissue is pressed with too high forces towards the jaw parts joint.A capa was not initiated.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8970638
• MDR Text Key: 156796482
• Report Number: 9610612-2019-00614
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K962493
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1