MAUDE Adverse Event Report: AESCULAP AG MICRO-HALSTED FORCEPS DEL CVD 125MM; GENERAL SURGICAL INSTRUMENTS

Model Number BH109R

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.The investigation was carried out visually and microscopically with the digital microscope.We made a visual inspection of the instrument.Here we found an unknown labeling.Additionally we made an optical inspection of the fracture surface.We detected discolorations and signs of an intercrystalline fracture.We also discovered visible damaged tooth tips.Furthermore we made a visual inspection of the broken off part and an optical inspection of the fracture surface.Here we found discolorations and signs of an intercrystalline fracture.Batch history review: the device quality and manufacturing history records have been checked for the lot number (4508532874) and found to be according to the specification, valid at the time of production.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 micro-halsted forceps.It was reported that 8 clamps are broken at the hinge in the same time during the surgery.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: 9610612-2019-00706 ((b)(4) bh145r).

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: MICRO-HALSTED FORCEPS DEL CVD 125MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9193113
• MDR Text Key: 176778206
• Report Number: 9610612-2019-00705
• 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: BH109R
• Device Catalogue Number: BH109R
• Device Lot Number: 4508532874
• 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