MAUDE Adverse Event Report: AESCULAP AG BALFOUR ABDOMINAL RETRACTOR 200X235MM; GENERAL SURGICAL INSTRUMENTS

Model Number BV608R

Device Problem Failure to Clean Adequately (4048)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was an issue with bv608r - balfour abdominal retractor 200x235mm.According to the complaint description, the blades are not sealed.Blood enters the gaps and we can't guarantee the decontamination process will be successful.There was no described patient harm.Additional information was not provided.Additional patient information is not available.The malfunction is filed under aesculap (b)(4) reference (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Updated: d9 no product return.Based upon investigation results, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.Investigation results: visual investigation: product was not provided for investigation but pictures of the blades in question.Investigation was carried out based on the pictures provided.According to the drawing bv608r, the components are welded and grinded on the outer side.There is no welding seam on the opposite side.Furthermore, after consultation with a subject matter expert (sme) of "lifetime evaluation & processing"-department, we received an evaluation-document of a product with comparable areas.Based on this document, the connections in question can be cleaned and disinfected efficiently.Batch history review: the device quality and manufacturing history records will be checked for the leading device(s) lot number from the quality coordinator of the production plant.The results of the review will be documented in the notification.If review shows any conspicuities, the report will be updated and actions will be initiated.Review of the complaint history revealed that there are no similar complaints filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation of the pictures provided, product was according to specifications valid at the time of production.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: BALFOUR ABDOMINAL RETRACTOR 200X235MM
• Type of Device: GENERAL SURGICAL 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: 13772121
• MDR Text Key: 291842149
• Report Number: 9610612-2022-00075
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BV608R
• Device Catalogue Number: BV608R
• Device Lot Number: 4512317004
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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