MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION / VESSEL CLIPS

Model Number	PL569T
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a ligating clips m/l 12/box (part # pl569t) was used during an unknown procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the clips fell in situ.Reportedlym, after the third or fourth clip had been placed, the complete magazine suddenly detached into the abdominal cavity and had to be retrieved.The complaint device was returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components: pl510r - handle f/pl506r & pl508r - lot unknown.Pl536r - shaft compl.D:10mm l:370mm - lot 62424289.
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried out visually and microscopically.Visually, no deviation can be found at the components of the applier.The distal end of the cartridge is broken off, the sliding sheet is bent.Only one clip remained in the cartridge.A functional test was carried out successfully.The measurement of the jaws dimensions showed that they were no longer according the specification.These deviations were most likely caused by an overload situation, probably bending, during handling or reprocessing due to this deviations, a proper function auf the applier can not be guaranteed at all times.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.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.It is assumed that the failure occured due to an overload situation which caused the breakage of the jaw.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Common Device Name: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11720789
• Report Number: 9610612-2021-00334
• Device Sequence Number: 11817116
• Product Code: FZP
• UDI-Device Identifier: 04038653341375
• UDI-Public: 4038653341375
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PL510R - LOT UNKNOWN; PL536R - LOT 62424289
• Outcome Attributed to Adverse Event: Required Intervention