MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN ISOCOOL BIPOLAR FORCEPS; ELECTROSURGICAL CUTTING & COAG & ACCESSORIES

Model Number	8135200S
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
As reported by the affilliate, isocool forceps tips malfunctioned.After changing the tips, forceps again coagulated.One of the tips was broken.There were no reports of delay or patient harm.
Additional Manufacturer Narrative
Corrected field : device available for evaluati complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Udi: (b)(4).It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.Upon completion of the investigation, a follow-up report will be submitted.The device was returned for evaluation.The sample was visually inspected and had no visual abnormalities; although it was noted the tips were different sizes.A multimeter was used to measure the resistance between two points along each tip.The device performed as intended and met specifications.A review of manufacturing records found no anomalies during the manufacturing process.Based on the results of the investigation, the reported issue could not be confirmed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: CODMAN ISOCOOL BIPOLAR FORCEPS
• Common Device Name: ELECTROSURGICAL CUTTING & COAG & ACCESSORIES
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham 02767
• MDR Report Key: 7738464
• Report Number: 1226348-2018-10537
• Device Sequence Number: 19095222
• Product Code: GEI
• UDI-Device Identifier: 10886704040149
• UDI-Public: (01)10886704040149(10)HQ0473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 8135200S
• Device Catalogue Number: 8135200S
• Device Lot Number: HQ0473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 03/07/2019
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 09/04/2018; 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1