MAUDE Adverse Event Report: AESCULAP AG LIGATURE CLIP 12 MAG.= 144 PCS.; LIGATION / VESSEL CLIPS

Model Number PL572T

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a ligature clip 12 mag.= 144 pcs (part # pl572t) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, 5 millimeter (mm) clips were used with the device.The operator was able to place the first clip into the patient without issue, however, when the next clip was fire, the entire magazine came loose in the patient's abdomen.The magazine was retrieved, and reattached, but when it was re-tested outside the patient, the magazine came loose.A new clip magazine was then used.After attaching to the pliers and being careful to firmly seat the magazine, the device was tested outside the patient, but the issue recurred.The whole magazine pushed away from the pliers when the clips were fed and detached from the forceps.A third magazine was then able to be used to successfully complete the procedure.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a ligature clip 12 mag.= 144 pcs (part # pl572t) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, 5 millimeter (mm) clips were used with the device.The operator was able to place the first clip into the patient without issue, however, when the next clip was fire, the entire magazine came loose in the patient's abdomen.The magazine was retrieved, and reattached, but when it was re-tested outside the patient, the magazine came loose.A new clip magazine was then used.After attaching to the pliers and being careful to firmly seat the magazine, the device was tested outside the patient, but the issue recurred.The whole magazine pushed away from the pliers when the clips were fed and detached from the forceps.A third magazine was then able to be used to successfully complete the procedure.The complaint device was returned to the manufacturer for evaluation.An additional medical intervention was necessary.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: the investigation was carried out visually and microscopically.Here we found broken off noses, broken off latches and clip jams.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(2) with this error pattern.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: according to the quality standard and dhr files a material defect and a production error can be excluded.There are no hints of a pre-damage or similar.If the cartridge is engaged not completely, has not been mounted correctly or was damaged during inserting, there is an impairment of product functionality.A too fast application, damaged cartridge during inserting or a cartridge which is engaged not completely could also lead to the described errors.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.According to the investigation results, a product safety case (psc) was initiated.Any action regarding capa will be addressed with this case.

• Brand Name: LIGATURE CLIP 12 MAG.= 144 PCS.
• 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: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13445855
• MDR Text Key: 286335205
• Report Number: 9610612-2022-00009
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 04038653341856
• UDI-Public: 4038653341856
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K081031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL572T
• Device Catalogue Number: PL572T
• Device Lot Number: 52699410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention