MAUDE Adverse Event Report: AESCULAP AG TENACULUM FORCEPS D:5/310MM; REUSABLE INSTRUMENTS

Model Number	PO224R
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Additional information / investigation results will be provided in a supplemental report, if available.
Event or Problem Description
It was reported that there was an issue with a tenaculum forceps.The device bent/broke at a 90 degree angle while being used to grasp the uterus.The instrument was slowly backed out of the patient after the removal of the trocars without any further malfunction.There was a unknown delay due to the event.This occurred during a laparoscopic procedure.There was no described patient harm.Additional information has been requested.The adverse event is filed under xc reference (b)(4).
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough failure description of the product 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.Explanation and rationale: unfortunately due to a lack of data and without the product we cannot determine the exact root cause for the mentioned deviation.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.The exact cause cannot be determined.Based upon the investigations results a capa is not necessary.

• Brand Name: TENACULUM FORCEPS D:5/310MM
• Common Device Name: REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11517421
• Report Number: 2916714-2021-00042
• Device Sequence Number: 3412460
• Product Code: GEI
• UDI-Device Identifier: 04046963331382
• UDI-Public: 4046963331382
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021
• Report Date (Section F): 03/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: PO224R
• Device Catalogue Number: PO224R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 03/18/2021