MAUDE Adverse Event Report: AESCULAP INC TISCHLER BIOPSY FORCEPS ALLIGATOR 250MM; GYNAECOLOGY AND OBSTETRICS

Model Number MG076R

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an issue with the biopsy forceps.During use in a colpopexy procedure, the forcep became "stuck".The malfunction caused a 10-15 minute delay.After inspection of all the forceps in the clinic, it was noted that the devices desperately needed oil in the jaws and slide bar.The forceps were then working properly.There was no patient harm or intervention required.Additional information was not provided.

Manufacturer Narrative

Supplier: (b)(4).The facility could no longer identify the exact device in use.After all devices were oiled, they worked properly.Multiple attempts had been made to receive the product; the lot number was unknown.Evaluation: (reference number (b)(4)).There was no item to evaluate.There were no findings or actions.

• Brand Name: TISCHLER BIOPSY FORCEPS ALLIGATOR 250MM
• Type of Device: GYNAECOLOGY AND OBSTETRICS
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa PA 18034
• MDR Report Key: 9511593
• MDR Text Key: 177562286
• Report Number: 2916714-2019-00140
• Device Sequence Number: 1
• Product Code: HTD
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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: MG076R
• Device Catalogue Number: MG076R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1