MAUDE Adverse Event Report: AESCULAP AG JAW INS.CLINCHING GRSP FEN.3.5MM 290MM; MONOPOLAR REUSABLE INSTRUMENTS

Model Number	PO346R
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that a jaw ins.Clinching grsp fen.3.5mm 290mm (part # po346r) was used during a endoscopic hernia surgery performed on (b)(6) 2022.According to the complainant, during the surgery, the jaw of the laparoscopic instrument fell off in the patient.The fragment was retrieved.The complaint device was not returned to the manufacturer for evaluation.An additional medical intervention was necessary.Additional information was not provided nor available.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).Involved components: po381r - handle with ratchet for 3.5mm instr.- lot unkown.Pm986p - insulated outer tube 3.5/3.5mm 290mm - lot unknown.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Updated h6: codes.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.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 1(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.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.
Event or Problem Description
Involved components: po381r - handle with ratchet for 3.5mm instr.- lot unknown.Pm986p - insulated outer tube 3.5/3.5mm 290mm - lot unknown.

• Brand Name: JAW INS.CLINCHING GRSP FEN.3.5MM 290MM
• Common Device Name: MONOPOLAR REUSABLE INSTRUMENTS
• 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: 13809125
• Report Number: 9610612-2022-00040
• Device Sequence Number: 11300198
• Product Code: GEI
• UDI-Device Identifier: 04046963520595
• UDI-Public: 4046963520595
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K940936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: PO346R
• Device Catalogue Number: PO346R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PM986P - LOT UNKNOWN.; PM986P.; PO381R - LOT UNKNOWN.; PO381R.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female