MAUDE Adverse Event Report: AESCULAP AG DUROGRIP MATHIEU NEEDLE HOLDER FIN.200MM; BASIC INSTRUMENTS

Model Number BM153R

Device Problem Material Fragmentation (1261)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

It was reported to aesculap ag that a durogrip mathieu needle holder fin.200mm (part # bm153r) was used during a gynecological caesarean section surgical procedure performed on (b)(6) 2022.According to the complainant, the tungsten tip broke off during surgery and remained in patient.The doctor confirmed that something remained in the patient after the abdomen was closed as observed on x-ray images.Following this observation, it was confirmed that part of the tungsten carbide had broken off.The physician asked the patient if they wanted the part removed, and the patient refused.The complaint device has not been returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

This is a similar device report.The affected device is not marketed in the us.Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

This is a similar device report.The affected device is not marketed in the us.Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap ag that a durogrip mathieu needle holder fin.200mm (part # bm153r) was used during a gynecological caesarean section surgical procedure performed on (b)(6) 2022.According to the complainant, the tungsten tip broke off during surgery and remained in patient.The doctor confirmed that something remained in the patient after the abdomen was closed as observed on x-ray images.Following this observation, it was confirmed that part of the tungsten carbide had broken off.The physician asked the patient if they wanted the part removed, and the patient refused.The complaint device has not been returned to the manufacturer for evaluation.Although requested, additional information has not been made available.The adverse event is filed under (b)(4).

Event Description

Correction: adverse event changed to product problem.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: DUROGRIP MATHIEU NEEDLE HOLDER FIN.200MM
• Type of Device: BASIC 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: 13444116
• MDR Text Key: 285935799
• Report Number: 9610612-2022-00035
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653028580
• UDI-Public: 4038653028580
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM153R
• Device Catalogue Number: BM153R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/03/2022
• Supplement Dates Manufacturer Received: 02/21/2022
• Supplement Dates FDA Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Sex: Female