MAUDE Adverse Event Report: AESCULAP AG ROCHESTER-PEAN FORCEPS CVD 160MM; HAEMOSTATIC FORCEPS

Model Number	BH443R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
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 bh443r - rochester-pean forceps cvd 160mm.According to the complaint description, the instrument broke during surgery.It was reported that the rochester-pean forceps cvd 160mm (pean clamp) broke during a cholecystectomy on (b)(6) 2021.An x-ray was required to ensure that the device fragment was successfully removed from the surgical field.It is not known at this time the method (or tool) that was used to remove the fragment.An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
The investigation will be updated, if the product can be forwarded to the manufacturer.At the time of this report, the product was received in usa and lot number was updated.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.
Event or Problem Description
The adverse event is filed under aag reference (b)(4) ((b)(4)).
Additional Manufacturer Narrative
Investigation results: investigation was carried out visually and microscopically.Here we have found that the male jaw is broken.Additionally we detected yellow-brown and brown discolorations, cracks and signs of an intercrystalline fracture.Batch history review: the device quality and manufacturing history records (dhr) have been checked for the lot number and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.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, the root cause of the reported issue can be traced back to a manufacturing-related, reprocessing-related or design-related failure.Specifically, it is assumed that that the breakage was caused by stress-corrosion cracking.Possibly a pre-damage could caused due to a manufacturing deviation by unfavourable production-related circumstances, such as sharp-edged milling transitions, as well as critical material tensile stress conditions due to straightening work.Additionally it appears that the cracks are ferrite rusticities / ferrite microstructures.Due to the existing pre-damage or weak point, the reprocessing was fracture-triggering.The microstructure, chemical composition, hardness and material toughness comply with the specifications.The material as well as the heat treatment can be excluded as cause of damage/breakage.Various tests are carried out to derive measures to prevent and or minimize material breakage.In addition to the boiling stress test and a test plan was also prepared.Based upon the investigations results a modification was initiated.

• Brand Name: ROCHESTER-PEAN FORCEPS CVD 160MM
• Common Device Name: HAEMOSTATIC FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11595017
• Report Number: 9610612-2021-00239
• Device Sequence Number: 4224864
• Product Code: HRQ
• UDI-Device Identifier: 04038653026562
• UDI-Public: 4038653026562
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/14/2021

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: BH443R
• Device Catalogue Number: BH443R
• Device Lot Number: 4509348313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 06/17/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/18/2021; 07/14/2021
• 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