MAUDE Adverse Event Report: AESCULAP AG SURGICAL SCISSORS STR B/B 150MM; GENERAL SURGICAL INSTRUMENTS

Model Number BC315R

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

Visually no deviations can be found at the provided instruments.However one pair of scissors passed the cutting performance test.The other pair of scissors failed, the described error could be confirmed.There are no similar complaints against the same lot number(s) with this error pattern.Due to the current deviation and according the investigation, the root cause of the problem is most probably manufacturing related.As a measure the responsible q-coordinator of the production plant has been informed.

Event Description

It was reported that there was an issue with surgical scissors.During inspection of the device, it was noted that the tip was not cutting properly.There was no patient involvement.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under (b)(4) reference (b)(4).Involved components: bc315r - 4511506274-surgical scissors str b/b 150mm.

• Brand Name: SURGICAL SCISSORS STR B/B 150MM
• 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: 10627079
• MDR Text Key: 209793854
• Report Number: 9610612-2020-00550
• Device Sequence Number: 1
• Product Code: LRW
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC315R
• Device Catalogue Number: BC315R
• Device Lot Number: 4511506274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2020
• 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