MAUDE Adverse Event Report: AESCULAP AG CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.; LAPAROSCOPIC SURGERY

Model Number PL579T

Device Problem Break (1069)

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

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 procedure, the tip of the plastic cover on the cartridge broke off.An x-ray was used to find and retrieve the piece successfully.There was no patient harm.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: the cartridge arrived in a clean status with a visible damaged nose but without the broken off fragment.The investigation was carried out visually and microscopically with the digital microscope.Tip of the cartridge broke off.During a surgery the tip of the plastic cover of the clip cartridge broke and the particle was found abdominal by using an x-ray.We made a visual inspection of the cartridge.Here we found a used cartridge with five clips.We also detected a broken off tip.No deformed metal sheet was discovered.Additionally we made an optical inspection of the fracture surface.No abnormalities were found.Batch history review: a review of the device quality and manufacturing history records is not possible because the batch number is unknown.Conclusion and root cause the root cause of the problem is most probably usage related.Rationale according to the quality standard a material defect and production error can be excluded.No pores or inclusions could be found on the point of rupture.Investigations lead to the assumption that the breakage was caused by an improper handling.The breakage could have been during application by contact with another instrument.

• Brand Name: CHALLENGER TI-P ML-LIGAT.CLIPS 12 CARTR.
• Type of Device: LAPAROSCOPIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8970635
• MDR Text Key: 156796591
• Report Number: 9610612-2019-00613
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K081031
• 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: 10/14/2019

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: PL579T
• Device Catalogue Number: PL579T
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1