MAUDE Adverse Event Report: AESCULAP AG GERALD FORCEPS DEL STR 175MM

Model Number	BD228R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 to aesculap ag that a gerald forceps del str 175mm (part # bd228r) was used during a cardiac surgery performed on an unknown date.According to the complainant, during the surgery, the tip of the device broke.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference cc (b)(4).
Additional Manufacturer Narrative
Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: the investigation was carried out visually and microscopically.We found a misaligned working end.The mentioned deviation "tip broken" could not be determined.Investigations lead to the assumption that the misaligned working end was caused by an improper handling due to a mechanical overload situation.Possibly and excessive force has been applied on the instrument or the possibility of torsion or high leverage with the instrument.Furthermore according instruction for use the following warning and points must be observed: "prior to each use, inspect the product for loose, bent, broken, cracked, worn or fractures components always carry out a function test prior to each use of the product." (extract of the ifu of the device.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.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.Based upon the investigations results a capa is not necessary.

• Brand Name: GERALD FORCEPS DEL STR 175MM
• Common Device Name: FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11673337
• Report Number: 9610612-2021-00301
• Device Sequence Number: 19596104
• Product Code: HTD
• UDI-Device Identifier: 04038653023189
• UDI-Public: 4038653023189
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BD228R
• Device Catalogue Number: BD228R
• Device Lot Number: 4502398915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1