MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GEOMED SUPERCUT METZENBAUM SCISSORS DELICATE; CARDIOVASCULAR SCISSORS

Model Number 100262

Device Problem Material Fragmentation (1261)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

According to the healthcare facility, the device broke during a knee arthroscopy with multiple ligament repairs with allografts.While cutting soft tissue, the shaft of the handle near the lockbox broke, flew back and nearly hit the surgeon in the face.The staff irrigated heavily to make sure all small pieces were removed.It was reported that no part of the instrument fell into the surgical site that could be seen with the naked eye.Multiple x-rays were taken.There was a surgical delay of 30 minutes as the staff addressed the issue.The procedure was completed with a replacement pair of scissors.The patient had to endure extra minutes of anesthesia and more doses of radiation than originally planned for, but the patient's outcome was excellent.

Manufacturer Narrative

Despite several attempts to obtain the device or photographs of the device, the scissors were not returned.Therefore, it was impossible to perform an evaluation of the device.It was also impossible to determine the batch code of the device in order to review the dhr.Review of complaint history did not reveal any similar nonconformances.

Manufacturer Narrative

The manufacturing date is unknown.

Manufacturer Narrative

The scissors have been returned to the manufacturer and inspected.It was observed that the device was refurbished by unknown third parties, including resharpening of the cutting edges and realignment by means of repeated blows on the joint, conceivably weakening the instrument and ultimately causing it to break.The device history record was reviewed.No issues were found.

• Brand Name: GEOMED SUPERCUT METZENBAUM SCISSORS DELICATE
• Type of Device: CARDIOVASCULAR SCISSORS
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 14217717
• MDR Text Key: 299306080
• Report Number: 8010168-2022-00003
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100262
• Device Catalogue Number: 102-310 / AA 881-18-01
• Device Lot Number: AA1902
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention