MAUDE Adverse Event Report: AESCULAP AG CRILE FORCEPS CVD 140MM; GENERAL SURGICAL INSTRUMENTS

Model Number BH145R

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: the instruments arrived in a clean status with visible damage and the broken off parts.One broken off part is missing.The investigation was carried out visually and microscopically with the digital microscope.We made a visual inspection of the instruments.Here we found an unknown labeling.We also detected visible damaged tooth tips.Additionally we made an optical inspection of the fracture surface.Here we discovered discolorations and signs of an intercrystalline fracture.We made a visual inspection of the broken off parts and an optical inspection of the fracture surface.Here we found discolorations, secondary damages and signs of an intercrystalline fracture.All received parts were inspected optical.The results and pictures serve as a reference for all parts.Batch history review: the device quality and manufacturing history records will be checked for the lot number (4508680821) from the quality coordinator of the production plant.The results of the review will be documented in pc 500463802.If the review shows any conspicuities, the report will be updated and actions will be initiated.No similar incidents have been filed with products from this batch.Conclusion and root cause: the root cause of the problem is most probably reprocessing related.Rationale: investigations lead to the assumption that the breakages were caused by stress-corrosion cracking.It appears that the brown discolorations are rust / corrosion and the dark discoloration are signs of an old crack.There is the possibility that the visible damaged tooth tips were caused due to an improper handling by a mechanical overload situation or manufacturing error by straightening work.The secondary damages could have been caused due to movement of both parts each other after a crack.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.

Event Description

It was reported that there was an issue with crile forceps.It was reported that 8 clamps are broken at the hinge in the same time during the surgery.The procedure was cardiac.There was no patient harm.There was no medical intervention necessary.Additional information was not provided.The adverse event/malfunction is filed under aag (b)(4).Associated medwatch-reports: 9610612-2019-00705 ((b)(4) bh109r).

Manufacturer Narrative

Upon further review and clarification, the report was reassessed and found to no longer require submission - no mulfunction or serious injury.(investigation previously submitted).

• Brand Name: CRILE FORCEPS CVD 140MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9193117
• MDR Text Key: 176778693
• Report Number: 9610612-2019-00706
• Device Sequence Number: 1
• Product Code: HRQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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
• Device Operator: Health Professional
• Device Model Number: BH145R
• Device Catalogue Number: BH145R
• Device Lot Number: 4508680821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1