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

Model Number BH443R

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report, if available.

Event 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).

Event Description

No updates.

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: failure description.No product available.Therefore a failure description at the product is not possible.Investigation: no product available.Therefore a failure description at the product is not possible.Pictorial documentation: no product and no pictures are available.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.Explanation and rationale: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a material defect and production error can most probably be excluded.If further investigations are required, the product should be provided for examination.According the instruction for use (ifu) the following caution must be observed: safe handling and preparation section.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot yet be determined.Corrective action: there is no capa necessary.

Manufacturer Narrative

Product was received by manufacturer and evaluated.Leading device.Reference code (b)(4).Device name rochester-pean forceps cvd 160mm.Serial number n/a.Batch number 4509348313.Manufacturing date 01.02.2018.Failure description: the products arrived in a clean status with visible damage and the broken off jaw.Investigation: the investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq.-nr.(b)(4)) and the digital-camera panasonic dmc tz8".We made a visual inspection of the product.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 all leading device(s) lot numbers 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.Explanation and rationale: investigations lead to the assumption 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 according to sa-dddd-m- 5-2-04-151-0-b-de/en, a test plan was also prepared.Conclusion and root cause: due to the current deviation and according to explanation and rationale, the root cause of the problem is most probably reprocessing-related, and possibly design or manufacturing related.Corrective action: a change with application number (b)(4) has been initiated.

Event Description

No updates.

• Brand Name: ROCHESTER-PEAN FORCEPS CVD 160MM
• Type of Device: HAEMOSTATIC FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11594941
• MDR Text Key: 245564219
• Report Number: 2916714-2021-00044
• Device Sequence Number: 1
• Product Code: HRQ
• UDI-Device Identifier: 04038653026562
• UDI-Public: 4038653026562
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021,07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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: 03/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Distributor Facility Aware Date: 03/02/2021
• Device Age: 37 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention