MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, BIPOLAR FORCEPS, PADDLE, 33CM; ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED

Catalog Number 0250080361

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

The device manufacture date is not known at this time.However, should it become available, it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).

Event Description

It was reported that the forceps did not work which resulted in the procedure converting to open surgery.

Manufacturer Narrative

Alleged failure: during surgery process, bipolar forceps can¿t power and can¿t made blood coagulation.So, this issue happened lead to the surgery options was changed from minimally invasive surgery to open operation.The procedure finished by used a new replacement.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.There is no probable root cause in relation to the complaint as it was unable to be confirmed.However, there is physical damage sustained to the unit which could have occurred as a result of excessive force or mishandling.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.The device manufacture date is not known.

Event Description

It was reported that the forceps did not work which resulted in the procedure converting to open surgery.

• Brand Name: PKG, BIPOLAR FORCEPS, PADDLE, 33CM
• Type of Device: ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 7537634
• MDR Text Key: 109039779
• Report Number: 0002936485-2018-00447
• Device Sequence Number: 1
• Product Code: OCZ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K973259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0250080361
• Device Lot Number: 1630115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other