MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number UNK_END

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.Since the part number has not been provided, the gtin and 510k number are not available at this time.If the part number becomes available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.

Event Description

It was reported that a shaver blade broke during surgery leading to post-operative nerve damage to the patient.

Manufacturer Narrative

The product was not returned for investigation; therefore, the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: broken blade during use probable root cause for the reported failure involving this device could not be determined due to insufficient information.The device manufacture date is not known.

Event Description

It was reported that a shaver blade broke during surgery leading to post-operative nerve damage to the patient.

• Brand Name: UNKNOWN_ENDOSCOPY_PRODUCT
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8817713
• MDR Text Key: 152009043
• Report Number: 0002936485-2019-00305
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_END
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other