MAUDE Adverse Event Report: AESCULAP AG SHAFT COMPL.D:10MM L:370MM; LIGATION / VESSEL CLIPS

Model Number PL536R

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/09/2019

Event Type  malfunction  

Manufacturer Narrative

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test successful, pl536r no visible abnormalities; functional test successful, pl569t #1 used condition; 5 of 8 clips withdrawn, pl569t #2 used condition; 4 of 8 clips withdrawn; broken nose; missing fragment.Investigation was carried out visually and micrsocopically.One of two clip cartridges has a broken off nose.The broken off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 pl569t shows 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.

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-reports: 9610612-2019-00614 ((b)(4) pl569t), 9610612-2019-00615 ((b)(4) pl520r).

• Brand Name: SHAFT COMPL.D:10MM L:370MM
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9293234
• MDR Text Key: 179126248
• Report Number: 9610612-2019-00720
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL536R
• Device Catalogue Number: PL536R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention