MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FEN.5/310MM; BIPOLAR REUSABLE INSTRUMENTS

Model Number PM438R

Device Problem Material Fragmentation (1261)

Patient Problem Burn(s) (1757)

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with pm438r - jaw ins.Bip.Maryland diss.Fen.5/310mm.According to the complaint description, the a risk of untimely coagualtion occured during surgery.Involuntary coagulation of the small intestine by the metal part upstream of the joint of the bipolar forceps during a laparoscopic appendectomy.A burn occured.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00380 ((b)(4)+ pm438r) 9610612-2021-00381 ((b)(4)+ pm438r) 9610612-2021-00382 ((b)(4)+ pm438r) 9610612-2021-00383 ((b)(4)+ pm438r).

Manufacturer Narrative

Investigation results: visual investigation: the investigation was carried out visually and microscopically.Visual inspection was carried out for all of the products.The products shows these or similar deviations and / or damages.Here we found a visible damaged and broken blue ceramic.We also detected a visible damaged and broken grey ceramic.Additionally we discovered misaligned jaws.Investigations lead to the assumption that the ceramic breakages and the misaligned jaw parts caused by an improper handling due to a mechanical overload situation.Possibly an excessive force has been applied on the instrument or the possibility of torsion or high leverage with the instrument.A major disadvantage of ceramics is their brittle fracture behavior (limited elongation and low fracture toughness).Metallic materials, on the other hand, are ductile and therefore break less frequently.They forgive easier constructive tolerances by relieving local stress peaks through elastic and plastic deformation.A damage isolation or ceramic could lead to an electrical malfunction.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 4(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 product safety case (psc 2021-039) was internally initiated for further investigations.

Event Description

Associated medwatch-reports: 9610612-2021-00381 (400511104 + pm438r), 9610612-2021-00382 (400511105 + pm438r), 9610612-2021-00383 (400511106 + pm438r).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2021-00380 (400511103 + pm438r) 9610612-2021-00381 (400511104 + pm438r) 9610612-2021-00382 (400511105 + pm438r) 9610612-2021-00383 (400511106 + pm438r) after reassessment this case was found to be non-reportable.The failure mode has changed, and the failure risk analysis adjusted from 4(5) severity to 2(5) severity.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
• Type of Device: BIPOLAR REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11842953
• MDR Text Key: 251412543
• Report Number: 9610612-2021-00380
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K003608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM438R
• Device Catalogue Number: PM438R
• Device Lot Number: 62429470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1