MAUDE Adverse Event Report: AESCULAP AG GOSSET ABDOMINAL RETRACTOR MED 55MM; GENERAL SURGICAL INSTRUMENTS

Model Number BV502R

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

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 gosset abdominal retractor.According to the customer description, it was reported that the failure was recognized during incoming goods inspection.Gosset abdominal retractor bv502r failed qa for the blades not sealed.No patient involvement.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

E1 - country updated.Preliminary investigation results: investigation is based on the pictures provided by customer.The device will be evaluated und this report will be updated accordingly.The device quality and manufacturing history records (dhr) will be checked for the lot number(s) from the quality coordinator of the production plant.The results of the review will be documented in the follow-up report.According to the pictures provided, the connection points of the device are according to the specifications valid at the time of production.Therefore the product is according to the specification.

Manufacturer Narrative

Investigation results: the device was returned for investigation.Investigation was carried out visually.According to the drawing bv502r, the components are welded and grinded on the outer side.There is no weld seam on the opposite side.After evaluation it was determined that the connection in question can be cleaned and disinfected efficiently.The brownish strains on the pictures cannot be found on the provided device.After evaluation it can be determined that the product is according to the specification valid at the time of production.No deviations can be found.Based on the investigations and results of the 8d report no capa is necessary.

• Brand Name: GOSSET ABDOMINAL RETRACTOR MED 55MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10398476
• MDR Text Key: 203516665
• Report Number: 9610612-2020-00368
• 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,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1