MAUDE Adverse Event Report: AESCULAP AG GOSSET ABDOMINAL RETRACTOR MED 55MM; ABDOMINAL SURGERY

Model Number BV502R

Device Problems Product Quality Problem (1506); Defective Component (2292)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

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 a abdominal retractor.According to the complaint description the blades and slideaway is not sealed in arm.There was no patient harm.Additional information was not provided nor available.The malfunction is filed under (b)(4).

Manufacturer Narrative

Investigation results: investigation was carried out visually and microscopically.According to the drawing bv502r, the components are welded and grinded on the outer side.There is no welding seam on the opposite side.It can be confirmed that the connection points are according to the specification valid at the time of production.The device quality and manufacturing history records (dhr) will be checked for the lot from the quality coordinator of the production plant.If the review shows any conspicuities, the report will be updated and actions will be initiated.No deviations can be found, the device is according to the specification.A capa was not initiated.

• Brand Name: GOSSET ABDOMINAL RETRACTOR MED 55MM
• Type of Device: ABDOMINAL SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10515545
• MDR Text Key: 206859734
• Report Number: 9610612-2020-00462
• Device Sequence Number: 1
• Product Code: FFO
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BV502R
• Device Catalogue Number: BV502R
• Device Lot Number: 4511586012
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1