MAUDE Adverse Event Report: AESCULAP AG JAW INS.ALLIGATOR FORCEPS 5MM 310MM; REUSABLE INSTRUMENTS

Model Number	PO615R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information/investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with po615r - jaw ins.Alligator forceps 5mm 310mm.The tip of an alligator grasper device broke off into the patient's abdominal cavity.After a methodical search and the use of fluoroscopy x-ray, the grasping tip was found and retrieved.The procedure was delayed for ten minutes due to the device malfunction.An additional medical intervention was necessary.This occurred during laparoscopic surgery.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results/ visual investigation: the product arrived in a clean status with a broken off jaw but the broken off part is missing.The investigation was carried out visually and microscopically.The investigatot found a deformed drawbar.Furthermore the investigator made a visual inspection of the fracture surface and they detected brown and dark discoloration and signs of an intercrystalline fracture.Batch history review: without an lot number and due to the lack of the information, 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.Investigation results lead to the assumption that the deformed drawbar and broken off jaw were caused by a mechanical overload situation due to an improper handling.There is also the possibility that the breakage was caused due to a stress-corrosion cracking.The brown discoloration could be corrosion and the dark discoloration could be a sign for an old crack.Due to an existing pre-damage or weak point, the reprocessing and an additional force were fracture-triggering.Based upon the investigations results a capa is not necessary.

• Brand Name: JAW INS.ALLIGATOR FORCEPS 5MM 310MM
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11032070
• Report Number: 9610612-2020-00891
• Device Sequence Number: 19030485
• Product Code: KNF
• UDI-Device Identifier: 04038653260256
• UDI-Public: 4038653260256
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K010752
• 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): 08/20/2021

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: PO615R
• Device Catalogue Number: PO615R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2020
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 08/20/2021
• 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