MAUDE Adverse Event Report: AESCULAP AG MONOPOLAR HANDLE WITH RATCHET; MONOPOLAR REUSABLE INSTRUMENTS

Model Number	PO959R
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
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 po959r - monopolar handle with ratchet.According to the complaint description, the 5mm laparoscopic tenaculum broke in the patient while holding the uterus.It did not shear off completely, this only happened when it was touched after removal.The work had to be interrupted and the trocar was removed to allow the instrument to come out.It was bent/sheared to almost 90 degrees.The outer plastic sheath, the inner metal sheath and the insert all broke off.This malfunction prolonged the surgery significant.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00266 ((b)(4) - po777r).
Additional Manufacturer Narrative
Additional information: d4 (udi).Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to change from leading material to involved component.All information regarding this case will be updated in 9610612-2021-00266 under aag reference: (b)(4).Investigation results: visual investigation: the shaft is fractured near the distal end.Vigilance investigator carried out the pictorial documentation visually and microscopically.The analysis of the fracture pattern illustrated a forced fracture due to overload, probably due to torsion and/or leverage during handling.No pores, inclusions or foreign bodies could be found on the point of rupture.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 4(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.Based upon the investigations results a capa is not necessary.
Event or Problem Description
An additional medical intervention was necessary.This event prolonged the surgery for 10-15 minutes.The adverse event is filed under aag reference: (b)(4).Involved components: pm973r - insulated outer tube 5/5mm 310mm - lot unknown.Po959r - monopolar handle with ratchet - lot unknown.

• Brand Name: MONOPOLAR HANDLE WITH RATCHET
• 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: 11517406
• Report Number: 9610612-2021-00267
• Device Sequence Number: 11953918
• Product Code: GEI
• UDI-Device Identifier: 04038653464098
• UDI-Public: 4038653464098
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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: PO959R
• Device Catalogue Number: PO959R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PM973R - LOT UNKNOWN.; PO959R - LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female