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

Model Number PL569T

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problems Hemostasis (1895); Patient Problem/Medical Problem (2688)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Further investigations at the production plant in order to be able to exclude dimensional deviations are ongoing.As soon as the results are available, this report will be supplemented.Manufacturing site evaluation: all component were available for investigation decontaminated.The provided components are in a used condition, different ats stamps can be found.Investigation - an investigation was carried out visually and microscopically.A functional test was carried out and all test-clips could be applied correctly.Shaft: the recommended maintenance date of pl536205 and pl53680 (sub-components) is exceeded.Visually, no failure could be detected on the components of the shaft as well as the handle.Handle: visually, no failure could be detected on the components of the shaft as well as at the handle.Cartridge: the distal end of the provided cartridge is broken off.One clip remained in the cartridge.No pores, inclusions or foreign bodies could be found on the point of rupture.Furthermore one bar of the metal sheet is bent.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 - the detaching of the cartridge was most likely caused by an overload situation.It is assumable that during application the tissue was pressed between the jaw parts too hard and thus the cartridge released from the shaft.This also could have triggered the breakage of the distal end and the bending of the metal sheet.No capa required.

Event Description

It was reported there was an intraoperative issue with the clips and applicator.During a laparoscopic procedure, a clip cartridge detached from the applicator and fell into the patient's abdomen.A second cartridge was used and while inserting the clip, it became "deformed"; it had been applied on an active bleeding site.The first cartridge as well as any fragments were successfully retrieved from the abdomen and the operation was completed.The surgery was delayed for more than 15 minutes.The patient outcome and condition was noted as "fine".No further information has been provided.Associated medwatches: 9610612-2019-00187 (shaft); 9610612-2019-00188 (handle).

Manufacturer Narrative

Investigation: a vigilance investigator carried out the pictorial documentation and a microscopic investigation.A functional test was carried out, all test clips could be applied correctly.The recommended maintenance date is exceeded.Visually, no failure could be detected on the components of the shaft or on the handle.The distal end of the provided cartiridge is broken off.No pores, inclusions or foreign bodies could be found on the point of rupture.Furthermore, one bar of the metal sheet is bent.Furthermore investigations at the production plant in order to be able to exclude dimensional deviations are ongoing.As soon as the results are available, this report will be supplemented.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: the detaching of the cartridge was most likely caused by an overload situation.It is assumable that during application, the tissue was pressed between the jaw parts too hard, and thus, the cartridge released from the shaft.This also could have triggered the breakage of the distal end and bending of the metal sheet.No capa is necessary.

• 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: 8444698
• MDR Text Key: 139591085
• Report Number: 9610612-2019-00189
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• 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: 03/18/2019
• Distributor Facility Aware Date: 03/27/2019
• Date Manufacturer Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention