Snowden-Pencer 88-1088Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403151675), received between Jul 22, 2022 and Jan 13, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2023Overheating of Device; Overheating of Device

  MAT# 88-1088 LOT# UNKNOWN. VERBATIM: PATIENT POSSIBLY BURNED BY SUCTION PORT ON RETRACTOR DURING CASE RESULTING IN TWO CIRCULAR BLISTERS ON PATIENT SKIN. 03JAN2022 ADDITIONAL INFORMATION: 1. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? [] BREAST RECONSTRUCTION WITH TISSUE EXPANDERS. 2. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT¿S BODY, AND IF SO HOW WAS IT RETRIEVED?[] NO. 3. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY?[] NO. 4. WHAT WAS THE PATIENT¿S OUTCOME?[] BLISTERS WERE NOTED IN 2 AREAS ON THE PATIENT¿S CHEST. 5. WAS THE PROCEDURE COMPLETED AS PLANNED?[] YES. 6. CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION AND PROVIDE A SHIPPER ADDRESS?[] YES. 7. WHAT IS THE LOT NUMBER?[] NA. 8. DO YOU HAVE PHOTOS OF THE REPORTED ISSUE ON THE INSTRUMENT?[] NO.

  Patient problems: Blister

  MAUDE report 16163529 ↗
• MalfunctionJul 22, 2022Smoking; Smoking

  VERBATIM: INADEQUATE LIGHT COMING FROM TEBBETTS RETRACTORS. CUSTOMER HAS (4) EACH OF FOLLOWING: 88-1086, 88-1087, 88-1088 AND 88-1090. JUST FOR SOME HISTORY. ONE OF THE SURGEONS A WEEK OR 2 AGO HAD ISSUE WITH LACK OF ILLUMINATION WHEN USING THE RETRACTOR SET. I (BIOMED) RESPONDED AND FOUND THAT THEY WERE USING A KARL STORZ LIGHT SOURCE WITH A 4-WAY TURRET ON IT. GENERALLY, THIS TURRET ALLOWS FOR CONNECTION OF 4 DIFFERENT MANUFACTURER¿S LIGHT CABLES HOWEVER, THE SNOWDEN PENCER CABLE DOES NOT POSITIVELY MATCH UP TO ANY OF THEM. THE LIGHT SOURCE ITSELF WAS RUNNING AT 100% INTENSITY AND 43 HRS OF A 500 HR BULB LIFE. THE NURSE WAS ATTEMPTING TO HOLD YOUR3MM CABLE INTO ONE OF THE HOLES ON THE TURRET. JUST MOVING THE CABLE AROUND IN THAT TURRET HAS SOME EFFECT ON THE AMOUNT OF LIGHT GETTING TO THE RETRACTOR. I HAD SUGGESTED THEY TRY TO USE OUR ¿NEW¿ STRYKER LED LIGHT SOURCE AS AT LEAST IT ACCEPTS YOUR CABLE BETTER AND HOLDS IT IN PLACE POSITIVELY. AFTER THE CASE I HAD THE LIGHT SOURCE AND THE RETRACTOR SET BROUGHT TO ME. I TESTED IT A BIT WITH THE KARL STORZ XENON LIGHT SOURCE AND DID NOT GET WHAT I WOULD CONSIDER TO BE ¿ADEQUATE¿ LIGHT OUT OF YOUR 3MM CABLE. I DID A COMPARATIVE, SIDE BY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089148 ↗