MAUDE Adverse Event Report: AESCULAP AG CHOLANGIOGRAPHY CLAMP 5MM 330MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PL100R
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site 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 that there was an issue with pl100r - cholangiography clamp 5mm 330mm.According to the complainant, the tip of the device broke off.Forceps involved in patient incident where tip of forceps snapped off during surgery.Procedure was delayed as patient required x-ray to locate broken tip.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
Additional Manufacturer Narrative
Investigation results: visual investigation: investigation was carried out visually and microscopically.Here we found a broken off jaw and a deformed connection point of the jaw.In addition, we carried out a visual inspection of the fracture surface.No abnormalities were detected.According to the quality standard a material defect and production error can be excluded.No abnormalities could be found on the point of rupture.Investigations lead to the assumption that the broken off jaw and the deformed connection point of the jaw were caused by a mechanical overload situation due to an improper handling.Possibly an excessive force has been applied on the instrument or the possibility of torsion or high leverage with the instrument.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 2(5) x probability of occurrence3(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.Based upon the investigations results a capa is not necessary.

• Brand Name: CHOLANGIOGRAPHY CLAMP 5MM 330MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11517370
• Report Number: 9610612-2021-00173
• Device Sequence Number: 3678755
• Product Code: GEI
• UDI-Device Identifier: 04038653181094
• UDI-Public: 4038653181094
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K922576
• 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,Followup
• Report Date (Section B): 07/19/2021

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: PL100R
• Device Catalogue Number: PL100R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 06/22/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 05/18/2021; 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention